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Rosuvastatin/Fenofibrate Film coated tablets 5mg+160mg 10mg +160mg, 20mg+160mg Description: The product delivers in immediate release form Rosuvastatin and Fenofibrate systemically equivalent to Crestor (Rosuvastatin) and Secalip Supra (Micronized Fenofibrate 160mg). Indication: Substitution indication for patient already on Rosuvastatin and Fenofibrate. Rosuvastatin is indicated first line: • In mixed dyslipidaemia • For the prevention of major cardiovascular events in patients at high- risk Fenofibrate is indicated in patients with mixed dyslipidaemia at high CV risk, in addition to statin when TG and HDL-C are not adequately controlled. Relevant patient groups: High level of triglycerides is a broad-based condition which affects more than 25 million patients across Europe. Familial combined hyperlipidaemia is a highly prevalent mixed dyslipidaemia (1:100-200) and an important cause of premature coronary arteries disease. Additionally, there has been a significant interest in vascular inflammation as a predictor for CV events. CRP is considered as a strong marker for vascular inflammation, and fenofibrate (along with the combination of rosuvastatin/fenofibrate) has significant proven data on reduction of CRP. Key selling point • Elevated TG increase CV risk even when LDL-C is controlled • Fenofibrate reduced CV risk in patients with high TG and low HDL-C in combination with statin • Fixed-dose combination improve compliance to treatment and clinical outcomes

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